# China NMPA Product Recall - Subcutaneous implantable cardiodefibrillation electrode lead

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-international-medical-trade-shanghai-co-ltd/fe989de2-76d9-40f4-a7a6-ae5b6561b7a1/
Source feed: China

> China NMPA product recall for Subcutaneous implantable cardiodefibrillation electrode lead by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. published June 28, 2021. Recall level: Level 1 Recall. On June 28, 2021, the National Medical Products Administration (NMPA) published details regarding a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is voluntarily recalling its subcutaneous implantable defibrillator (FED) leads.
- Company Name: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Publication Date: 2021-06-28
- Product Name: Subcutaneous implantable cardiodefibrillation electrode lead
- Recall Level: Level 1 Recall
- Recall Reason: Completed the design enhancement of the subcutaneous implantable cardiac defibrillation electrode lead and replaced the affected/original product with the newly designed product.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Summary: On June 28, 2021, the National Medical Products Administration (NMPA) published details regarding a supplementary voluntary product recall initiated by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. This recall is an update to an earlier action reported on January 28, 2021.
The company is voluntarily recalling its Subcutaneous Implantable Defibrillator (SDF) Leads and Subcutaneous Electrodes. This Class I recall indicates a high potential for serious adverse health consequences or death associated with the affected devices. The underlying issue stems from the original design of these electrode leads.
In response, Boston Scientific has completed a design enhancement for the SDF electrode leads. These improved leads are now available in the Chinese market and are intended to replace the previously affected or original products. The recall is managed under the regulatory framework of the National Medical Products Administration (NMPA), with information disseminated through the Shanghai Municipal Drug Administration.
The required action involves the voluntary recall of the specific subcutaneous electrodes by Boston Scientific. The availability of the redesigned, enhanced leads is crucial for facilitating the replacement of the original devices, thereby addressing the identified safety concerns and protecting patient health.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-international-medical-trade-shanghai-co-ltd/bc370948-4fe0-497a-93dd-bbac3a59dd56/